Diabetes
Conditions
Brief summary
The purpose of this study was to assure that consumers can successfully use the new version of A1CNow+ along with revised instructional materials.
Detailed description
The purpose of this study was to assure that consumers could successfully use the new version of A1CNow+ Test Kit along with revised instructional materials. The primary objective was to establish accuracy and secondary objectives were to establish precision, comprehension of instructional materials, and user feedback about the overall testing experience.
Interventions
DEVICEA1C Test Kit
Subjects tested 3 times with A1C test kits. Two tests were performed by the subject and the third test was performed by a healthcare professional (HCP). All results were compared to results from a laboratory glucose analyzer (TOSOH).
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adults (age 18 and older) approximately 80% being ≤55 years old 2. Persons with: * known diabetes (type 1 or type 2) and pre-diabetes - approximately 85% of subject population per site * no known diagnosis of diabetes - approximately 15% of subject population per site 3. Individuals who are interested in performing a test using the kit at home 4. Individuals willing to complete all study procedures (including venous draw and allowing site staff to perform finger punctures) 5. Individuals who are able to speak, read, and understand English 6. Individuals able to read out loud the first 5 lines of the A1C Test Kit instructional materials to demonstrate ability to read the print (may use glasses, if needed)
Exclusion criteria
1. Individuals taking prescription anticoagulants (such as Warfarin or heparin) or have clotting problems that may prolong bleeding. (Taking Plavix or aspirin daily is not excluded) 2. Individuals with known Rheumatoid Arthritis or other condition causing significant impairment of manual dexterity 3. Individuals with a known hemoglobin variant such as HbS or HbC 4. Individuals with any known disorder of the blood or blood-forming organs (such as recovery from blood loss, hemolytic anemia, or iron deficiency anemia) 5. Individuals who have received a blood transfusion within the 4 months prior to the study. 6. Persons with known infection with a bloodborne pathogen (e.g. HIV, hepatitis) 7. Individuals working for a competitive medical device company 8. Individuals who have participated in previous studies on the A1CNow+ product 9. Persons missing a digit or partial digits on the hand 10. Individuals with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study: * Significant visual impairment * Significant hearing impairment * Cognitive disorder * Any other condition as per investigator's discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY) | One hour | This outcome measure reports the number of A1c test results for which the percent difference (absolute value) between results from the subject meter and the laboratory method was less than or equal to 13.5%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Within Subject Coefficient of Variation CV (PRECISION) | One hour | The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of A1c self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root. |
| Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing | One hour | For the comprehension analysis, subjects were divided into 2 groups. One group (n=56 subjects) was given both written (Quick Reference Guide) and DVD instruction material. The other group (n=54 subjects) was given only written instruction material. First time failure (FTF) was defined as: * The subject could not use the product without HCP assistance. * The subject could not complete the test. User error rendered one or more parts unusable. * The subject completed the test after one or more mistakes; the result was an error code instead of a numerical value. |
| Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit | One hour | Subjects rated features of the A1C Test Kit, including 'Overall Testing Experience'. The rating scale was 4 (Excellent) to 1 (Poor). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects With and Without Diabetes Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes. | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | Subjects With and Without Diabetes |
|---|---|
| Age, Continuous | 46 years |
| Region of Enrollment United States | 110 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 110 |
| serious Total, serious adverse events | 0 / 110 |
Outcome results
Primary
Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY)
This outcome measure reports the number of A1c test results for which the percent difference (absolute value) between results from the subject meter and the laboratory method was less than or equal to 13.5%.
Time frame: One hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With and Without Diabetes | Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY) | Subjects had DVD and Written Instructions (n=101) | 94 number of A1c results |
| Subjects With and Without Diabetes | Number of A1C Results Either Equal To Or Within +/- 13.5% of the Laboratory Method (ACCURACY) | Subjects had Written Instructions only (n=77) | 71 number of A1c results |
Secondary
Average Within Subject Coefficient of Variation CV (PRECISION)
The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of A1c self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.
Time frame: One hour
Population: Precision Coefficient of Variation (CV)was analyzed using meter results from subject data that had numeric values for duplicate A1c self-tests. Subject data was not used in this outcome measure analysis when there had been a protocol deviation or when one (or both) A1c self-tests resulted in an error code.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects With and Without Diabetes | Average Within Subject Coefficient of Variation CV (PRECISION) | 4.57 average percentage CV |
Secondary
Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit
Subjects rated features of the A1C Test Kit, including 'Overall Testing Experience'. The rating scale was 4 (Excellent) to 1 (Poor).
Time frame: One hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With and Without Diabetes | Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit | 1 - Poor | 0 number of participants |
| Subjects With and Without Diabetes | Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit | 4 - Excellent | 65 number of participants |
| Subjects With and Without Diabetes | Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit | 3 - Very Good | 38 number of participants |
| Subjects With and Without Diabetes | Number of Participants Who Provided These Ratings For Overall Testing Experience With A1C Test Kit | 2 - Good | 7 number of participants |
Secondary
Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing
For the comprehension analysis, subjects were divided into 2 groups. One group (n=56 subjects) was given both written (Quick Reference Guide) and DVD instruction material. The other group (n=54 subjects) was given only written instruction material. First time failure (FTF) was defined as: * The subject could not use the product without HCP assistance. * The subject could not complete the test. User error rendered one or more parts unusable. * The subject completed the test after one or more mistakes; the result was an error code instead of a numerical value.
Time frame: One hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Subjects With and Without Diabetes | Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing | Subjects had DVD and Written Instructions | 11 percentage of subjects |
| Subjects With and Without Diabetes | Percentage of Subjects Who Experienced First Time Failures (FTF) During Testing | Subjects had Written Instructions Only | 40 percentage of subjects |